Implementing a real-time PCR-based method for sterility release testing of ATMPs

Supported by:

22 February 2023

3:00pm

Shares

2

Share via

• Facebook
• Like
• Twitter
• Pinterest
• LinkedIn
• Digg
• Del
• Tumblr
• VKontakte
• Print
• Email
• Flattr
• Reddit
• Buffer
• Love This
• Weibo
• Pocket
• Xing
• Odnoklassniki
• WhatsApp
• Meneame
• Blogger
• Amazon
• Yahoo Mail
• Gmail
• AOL
• Newsvine
• HackerNews
• Evernote
• MySpace
• Mail.ru
• Viadeo
• Line
• Flipboard
• Comments
• Yummly
• SMS
• Viber
• Telegram
• Subscribe
• Skype
• Facebook Messenger
• Kakao
• LiveJournal
• Yammer
• Edgar
• Fintel
• Mix
• Instapaper
• Copy Link

About this webinar

Currently established rapid methods for sterility testing of advanced therapy medicinal products (ATMPs) are mostly based on growth-based processes or the detection of metabolic activities. However, the requirements for real-time measurement and the testing of cell-containing products cannot be met with most of these methods.

In contrast, the real-time polymerase chain reaction (PCR) methodology offers a sterility test on cellular products with determination of the results on the same day. The required detection limit of < 100 CFU according to USP <1071> can be met.

A particular challenge here lies in the implementation of the molecular biological method in a multi-room Grade A cleanroom environment. Practical implementation of the technique, considering the possible risk factors will be presented.

Key takeaways

• Understand how real-time PCR can be implemented as sterility testing method for ATMPs
• Discover how Yasmin Heynen designed the setup and risk analysis for the implementation of the rapid sterility testing in a cleanroom class A
• Learn about the validation strategy at Sartorius including the authorities’ requirements for rapid microbiological methods
• Ask the experts questions about this process and benefit from their knowledge and guidance during the live event.